BACKGROUND: The efficacy and safety of the uncoated self-expandable Za metal stent for palliation of malignant distal biliary obstruction was prospectively analyzed. METHODS: Twenty-one patients with unresectable malignant tumors involving mid to distal common bile duct who presented with obstructive jaundice underwent endoscopic implantation of an uncoated self-expandable metal stent. Technical success with stent placement, adverse events, patient survival, duration of stent patency, and device performance were analyzed. RESULTS: Endoscopic biliary stenting was successful in all patients. No adverse events were encountered. The mean follow-up period of the 21 patients was 128 days (range, 3-263): 14 died of progressive disease at mean of 81 days (range, 3-210), 3 remain alive (at days 239, 250, and 263), and 4 were lost to follow-up (at days 90, 91, 92, and 116). The mean duration of stent patency was 249 days. Tumor ingrowth was observed in one patient (5%). Minor technical problems were encountered in 3 patients: 1 proximal deployment, 1 distal deployment, and difficulty associated with the delivery system in 1. CONCLUSIONS: The Za-metal stent provided effective palliation for patients with inoperable malignant biliary tumors. Although minor technical problems were encountered with stent deployment, the overall stent patency, efficacy, and safety profile appear satisfactory.
BACKGROUND: The efficacy and safety of the uncoated self-expandable Za metal stent for palliation of malignant distal biliary obstruction was prospectively analyzed. METHODS: Twenty-one patients with unresectable malignant tumors involving mid to distal common bile duct who presented with obstructive jaundice underwent endoscopic implantation of an uncoated self-expandable metal stent. Technical success with stent placement, adverse events, patient survival, duration of stent patency, and device performance were analyzed. RESULTS: Endoscopic biliary stenting was successful in all patients. No adverse events were encountered. The mean follow-up period of the 21 patients was 128 days (range, 3-263): 14 died of progressive disease at mean of 81 days (range, 3-210), 3 remain alive (at days 239, 250, and 263), and 4 were lost to follow-up (at days 90, 91, 92, and 116). The mean duration of stent patency was 249 days. Tumor ingrowth was observed in one patient (5%). Minor technical problems were encountered in 3 patients: 1 proximal deployment, 1 distal deployment, and difficulty associated with the delivery system in 1. CONCLUSIONS: The Za-metal stent provided effective palliation for patients with inoperable malignant biliary tumors. Although minor technical problems were encountered with stent deployment, the overall stent patency, efficacy, and safety profile appear satisfactory.